Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, distinctive and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose – to relieve patient suffering and enhance lives.

What We Do:

Neurocrine Biosciences (Nasdaq: NBIX) is a neuroscience-focused, biopharmaceutical company with more than 25 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems.

The company’s diverse portfolio includes two FDA-approved treatments INGREZZA® (valbenazine) for tardive dyskinesia and ORILISSA® (elagolix) for endometriosis*, as well as clinical development programs in multiple therapeutic areas, including Parkinson’s disease, chorea in Huntington disease, congenital adrenal hyperplasia, uterine fibroids* and polycystic ovary syndrome.* As part of a strategic collaboration with Voyager Therapeutics, Neurocrine Biosciences is also focused on the development of investigational gene therapy programs for the treatment of severe neurological diseases, including Parkinson’s disease and Friedreich’s ataxia. (*in collaboration with AbbVie)

About the Role:

Reporting to the Director of Analytical Development, the successful candidate will assist in developing a dynamic team responsible for assay development for the characterization and release of AAV-based gene therapy product candidates. The Scientist will be one of the subject matter experts in analytical activities associated with gene therapy development. These activities will focus on analytical method development, qualification, validation, and manufacturing sample testing under cGMP. The candidate is expected to have a background in the development of current PCR-based, immunological, and binding assays as well as familiarity with managing oversight of analytical method transfer and validation to CROs and external QC labs. This position requires strong team management and interpersonal skills.

This San Diego based position will require travel (up to 10%) to CROs and or collaboration sites.

Your Contributions (include, but are not limited to):

• Independently conduct assays for both qualitative and quantitative analysis of rAAV viral vectors including but not limited to proteins (ELISA, Western blot, silver stain/PAGE) and nucleic acids (qPCR, ddPCR, agarose gel electrophoresis)
• Perform routine assays on a weekly basis to determine product quality
• Generating and qualifying buffers, reagents, and standardards needed for routine assays
• Perform and optimize bioassays for determining product potency (vector transgene expression)
• Aseptic maintenance of cell cultures
• Further develop existing methods for improved performance
• Analyze data and generate high quality reports in a timely manner
• Write technical reports summarizing data as required
• Work with collaboration partners and CROs to understand, or guide the development of, all relevant analytical methods for the drug product candidates in the assigned portfolio of development programs
• Provide person-in-plant support for on-going analytical method transfer activities at collaboration partner(s) and CROs.

Requirements:

• BS in Biochemistry/Biology/Chemistry/Virology or a related field.
• Minimum 6 years of relevant experience in (Biotech/Biopharma) industry.
• Experience with the following techniques is important for qualifying for this position: qPCR, ddPCR, and ELISA.
• ​​Strong desire to learn multiple techniques and willingness to provide support as required.
• Significant attention to detail and accuracy in following protocols.
• Demonstrated ability to be highly productive in a fluid, fast-paced and teamwork environment.
• Good understanding of cell-based pharmacological assay design, development, and qualification.
• Excellent understanding and expertise in mammalian/insect cell culture.
• Familiarity with gene therapy products with a good understanding of the viral vector manufacturing process.
• Experience with cGMP compliance requirements, ICH guidelines for analytical testing, and excellent organizational skills.
• Self-motivated and comfortable working independently or in cross-functional teams, and an ability to meet timelines efficiently and productively.
• Excellent written and verbal communication skills.

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

Please click here to apply.